Hypertriglyceridemia
Conditions
Brief summary
Elevated cholesterol, including triglyceride levels, can lead to the development of cardiovascular disease in adulthood. A diet that is rich in omega-3 fatty acids (O3FA) can improve triglyceride levels in a way that is safe and does not require medication. This is a single-center, prospective, unblinded, randomized-controlled dietary intervention study to assess the impact of an omega-3 fatty acid diet compared to a standard lifestyle intervention on serum triglyceride in patients with hypertriglyceridemia. The study consists of an 8-week dietary treatment period followed by an 8-week observation period.
Interventions
OTHERDiet intervention
The intervention group will receive diet counseling and information to implement a standard lifestyle intervention plus omega-3 fatty acid enriched foods Diet assessment and counseling provided throughout study.
OTHERControl group
The control group will receive diet counseling and information to implement a standard lifestyle intervention Diet assessment and counseling provided throughout study.
Sponsors
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients who are 10 -17 years of age 2. BMI greater than or equal to the 85th percentile 3. Clinical serum triglyceride level \>150 mg/dl and \< 500 mg/dl performed between 3 months and 1 week prior to study visit 1 4. Ability to follow the study procedures and adhere to the diet counseling recommendations 5. Written parental permission and assent are obtained prior to any research procedures
Exclusion criteria
1. Type 2 DM (hemoglobin A1C \>6.6%) 2. Isotretinoin use 3. Chronic kidney disease (CKD) 4. Uncontrolled hypothyroidism 5. Warfarin use 6. Liver disease (NAFLD is allowed) 7. Renal disease 8. Corticosteroid use 9. Omega-3 fatty acid use (prescription or supplement) 10. Allergy to fish and/or nuts 11. Currently pregnant or planning to become pregnant during the course of this trial - confirmed by date of LMP/querying family 12. Any significant medical condition which the investigator believes would interfere with participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in serum triglyceride level after an 8-week diet intervention compared to baseline | 8 weeks | The study will test whether omega-3 fatty acid enriched diet is associated with a 20% or greater reduction in serum triglyceride levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change red blood cell omega-3 fatty acid content / index after an 8-week diet intervention compared to baseline | 8 weeks | Total levels of omega-3 fatty acids in red blood cell membrane phospholipids are measured. Percentages are reported as an index. The study will identify the index/total omega-3 fatty acid in red blood cells following initiation of an omega-3 fatty acid enriched diet. |
Countries
United States
Outcome results
None listed